PlainRecalls
FDA Devices Moderate Class II Terminated

Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598

Reported: February 12, 2020 Initiated: January 4, 2019 #Z-0965-2020

Product Description

Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598

Reason for Recall

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Details

Recalling Firm
Cook Inc.
Units Affected
13388 total
Distribution
Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, and the United Kingdom.
Location
Bloomington, IN

Frequently Asked Questions

What product was recalled?
Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598. Recalled by Cook Inc.. Units affected: 13388 total.
Why was this product recalled?
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 12, 2020. Severity: Moderate. Recall number: Z-0965-2020.